USA Series™ Long Autoclavable Foroblique Telescope 30°, 2.7mm Diamete

GUDID 00821925008427

Gyrus Acmi, Inc.

Rigid endoscope telescope Rigid endoscope telescope Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable

Primary Device ID	00821925008427
NIH Device Record Key	d090a1aa-bcdd-4738-80a8-5ce1e20ce6ab
Commercial Distribution Status	In Commercial Distribution
Brand Name	USA Series™ Long Autoclavable Foroblique Telescope 30°, 2.7mm Diamete
Version Model Number	REXG27L-30WA
Company DUNS	007198742
Company Name	Gyrus Acmi, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925008427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K890328

FDA Product Code

FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIH	Hysteroscope (And Accessories)